{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"94.5"},{"groupId":"OG001","value":"94.2"},{"groupId":"OG002","value":"94.8"}]}],"title":"TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66.7"},{"groupId":"OG001","value":"49.7"},{"groupId":"OG002","value":"67.2"}]}],"title":"Related TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5.5"},{"groupId":"OG001","value":"1.6"},{"groupId":"OG002","value":"5.7"}]}],"title":"Deaths"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33.3"},{"groupId":"OG001","value":"23.8"},{"groupId":"OG002","value":"36.5"}]}],"title":"Serious TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6.6"},{"groupId":"OG001","value":"3.2"},{"groupId":"OG002","value":"6.8"}]}],"title":"Drug regimen-related serious TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29.5"},{"groupId":"OG001","value":"23.8"},{"groupId":"OG002","value":"31.3"}]}],"title":"TEAEs leading to discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7.7"},{"groupId":"OG001","value":"5.3"},{"groupId":"OG002","value":"7.8"}]}],"title":"Drug regimen-related TEAEs leading to discon."},{"categories":[{"measurements":[{"groupId":"OG000","value":"10.4"},{"groupId":"OG001","value":"7.9"},{"groupId":"OG002","value":"10.4"}]}],"title":"TEAEs leading to study drug interruption"}],"denoms":[{"counts":[{"groupId":"OG000","value":"183"},{"groupId":"OG001","value":"189"},{"groupId":"OG002","value":"192"}],"units":"Participants"}],"description":"A serious adverse event was defined as any untoward medical occurrence that at any dose: ● Resulted in death ● Was life threatening ● Resulted in persistent or significant disability/incapacity ● Resulted in congenital anomaly or birth defect ● Required inpatient hospitalization or led to prolongation of hospitalization ● Other medically important events. Treatment-related indicates adverse events assessed by the Investigator as probably or possibly related to study treatment. Treatment emergent adverse events (TEAEs) were defined as adverse events (AEs) that started or worsened after starting administration of study drug through end of the study (i.e., the treatment-emergent period).","groups":[{"description":"Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.","id":"OG000","title":"Enzalutamide"},{"description":"Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.","id":"OG001","title":"Bicalutamide"},{"description":"Participants received enzalutamide in the double-blind and/or open-label period (including participants who switched from bicalutamide to enzalutamide).","id":"OG002","title":"Total Enzalutamide"}],"paramType":"NUMBER","populationDescription":"Safety Analysis Set (all participants who had initiated at least 1 dose of study drug)","reportingStatus":"POSTED","timeFrame":"From initiation of study drug up to 30 days after last dose of study drug or the 30-day safety follow-up visit, whichever was last (Median duration of treatment was 11.6 months in enzalutamide arm and 5.8 in bicalutamide arm, 12.6 in the total arm).","title":"Percentage of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"percentage of participants"}